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… Final FDA Guidance on Real-World Data and Real-World-Evidence for … data" (RWD) is defined by the FDA as “data relating to patient health status and/or the delivery of health care … The FDA clarifies that noninterventional studies are not considered clinical investigations under 21 Code of Federal …
… (RTI-HS) under the leadership of Utrecht University. The first project in which RTI-HS will be participating is a … case series analyses of specific severe adverse events as well as for monitoring the effectiveness of …
… States in 2023. Its impacts are already being felt – the first 10 drugs have been selected for the new Medicare Drug … understand disease burdens, unmet medical needs, and patient preferences. We support clinical trial design by …
… and how they are received by regulatory agencies such as FDA and EMA. Join us as our panel of experts discusses some … statistical analysis has developed since the method was first published. How these new developments have been used to answer problems such as sparse data, time-to-event data, treatment interaction effects, and how …
… Efficiency, Patient Access, and Costs Associated with Blood Platelet … studies; in addition to economic impacts, researchers considered potential clinical effects as well. Researchers … to transfusion. They found that the risk of adverse events was small for both methods, but the difference in …
… economic endpoints, which can be used to populate decision-analytic models (i.e., cost effectiveness or budget … models) Through our network of partners, we have access to patient charts in both developed and emerging markets. From … abstract data from their own patients’ charts based upon patient selection criteria developed by the study team. Our …
… product has received fast-track designation, like the US FDA’s Regenerative Medicine Advanced Therapies (RMAT) or the … Projects have included: Literature reviews Economic models Patient-centered outcomes assessment Health preference …
… need to address these unmet needs. Meeting patients’ needs first requires understanding them. To accomplish this, AbbVie … evaluate PsA patients’ disease experiences and treatment preferences. Creation of a Web-Based Survey Researchers … core outcome set and input from clinical experts, a patient living with PsA, and patient advocates. The survey …
… which will allow Medicare to directly negotiate - for the first time - pricing for certain drugs. The Maximum Fair Price … June 2022 were negotiation-eligible. From these, the first 10 drugs selected for the DPN Program were selected …
… US and many European countries as risks and benefits, patient-centricity, and comparative effectiveness continue to … REMS) Drug utilization studies Pragmatic clinical trials Time and motion Patient-reported outcomes and health-related … International Society for Pharmacoepidemiology (ISPE), the FDA, the EMA, and the European Network of Centres for …